Label: HEVERT DETOX LIVER- milk thistle, chelidonium majus root, and taraxacum officinale liquid

  • NDC Code(s): 54532-0033-5
  • Packager: Hevert Arzneimittel GmbH & Co KG
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 1, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "X" indicates a homeopathic dilution. For more information visit: www.hevertusa.com
    *
    pressure and pain in upper abdomen, constipation
    Carduus marianus TM*
    Chelidonium majus, radix 3X*
    Taraxacum officinale 3Xbloating
  • Uses

    For temporary relief of liver and gallbladder driven symptoms of indigestion, such as:

    • bloating
    • pressure and pain in upper abdomen
    • constipation

    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • Warnings

    For oral use only.

    Gallstones, occlusion of the bile ducts, jaundice and any other unclear or persistent discomfort in the upper abdomen may be serious.

    Consult a doctor promptly if any of these symptoms occur.

    Do not use if

    • you are allergic to Taraxacum, Carduus marianus or other plants from the daisy family (Compositae)
    • you suffer from liver diseases

    Stop use and ask a doctor if symptoms persist for more than 7 days, worsen or new symptoms occur.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away..

  • Directions

    • The liquid may be cloudy. Shake well before use.
    • Adults and children over 12 years of age: Take 20 drops in water 3 times daily.
    • Consult a physician for use in children under 12 years of age.
  • Other information

    • Store at 68 to 77 °F.
    • Tamper Evident:
      Do not use if tamper evident strip is broken or missing from base of bottle cap.
    • To report serious adverse events, call 1-855-387-6466.
  • Inactive ingredients

    57 % ethanol V/V, purified water

  • Questions?

    1-855-387-6466

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Hevert Pharmaceuticals, LLC
    Boulder, CO 80303

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

    NDC 54532-0033-5

    HEVERT®
    DETOX
    LIVER
    Homeopathic Medicine

    For the liver and
    gallbladder system

    1.7 fl oz (50 ml)
    57 % alcohol V/V
    Oral drops

    Made in Germany

    hEVERT

    Principal Display Panel - 50 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    HEVERT DETOX LIVER 
    milk thistle, chelidonium majus root, and taraxacum officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54532-0033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Milk Thistle (UNII: U946SH95EE) (Milk Thistle - UNII:U946SH95EE) Milk Thistle1 [hp_X]  in 50 mL
    Chelidonium Majus Root (UNII: FLT36UCF0N) (Chelidonium Majus Root - UNII:FLT36UCF0N) Chelidonium Majus Root3 [hp_X]  in 50 mL
    Taraxacum officinale (UNII: 39981FM375) (Taraxacum officinale - UNII:39981FM375) Taraxacum officinale3 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54532-0033-51 in 1 CARTON06/15/2016
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC06/15/2016
    Labeler - Hevert Arzneimittel GmbH & Co KG (318100617)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hevert Arzneimittel GmbH & Co. KG318100617MANUFACTURE(54532-0033)
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